WO42633 PHASE III

• Research type

  Research Study

• Full title

  A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ADJUVANT ATEZOLIZUMAB OR PLACEBO AND TRASTUZUMAB EMTANSINE FOR HER2-POSITIVE BREAST CANCER AT HIGH RISK OF RECURRENCE FOLLOWING PREOPERATIVE THERAPY.

• IRAS ID

  1003512

• Contact name

  Head, EU/International Pharmaceutical Division, PDR

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2020-003681-40

• Research summary

  Globally an estimated 2 million new breast cancer cases were diagnosed in 2018 (24% of all cancers in women). The majority of breast cancer in the Western world is diagnosed when the cancer is still confined to the breast, with or without lymph node spread. At these early stages (I-III, early breast cancer [EBC]), the largely asymptomatic disease is usually operable and can be treated with curative intent. Approximately 1 in 5 women diagnosed with EBC has human epidermal growth factor receptor 2 (HER2) positive disease (Wolff et al. 2013).

  The purpose of study WO42633 is to compare the effects, good or bad and safety of atezolizumab given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine. in patients with HER2-positive breast cancer (Tumors that have high levels of the HER2 protein (this is a receptor called “human epidermal growth factor receptor 2) who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or lymph nodes.
  Patients will be randomly allocated into 1 of 2 groups after some initial tests to ensure they are suitable to participate.

  The groups are:
  - Placebo in combination with trastuzumab emtansine administered intravenously (into a vein).
  - Atezolizumab in combination with trastuzumab emtansine administered intravenously (into a vein).

  Patients will receive up to 14 cycles of chemotherapy, each cycle will last 3 weeks, the total duration on treatment may be up to 10 months depending on how many cycles are completed. The follow up period may last for up to 10 years.

  1590 patients will be recruited globally. There will be approximately 160 patients recruited at 24 UK sites

  The study is sponsored by F. Hoffman La Roche
  Research Summary; Version Number 1 10th November 2020

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  21/NW/0035

• Date of REC Opinion

  18 Mar 2021

• REC opinion

  Further Information Favourable Opinion